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Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis

A Randomized Controlled Trial Comparing Surgical Outcomes of Decompressive Laminectomy Versus Decompressive Laminectomy With Transpedicular Screw Fixation in Multilevel Lumbar Spinal Stenosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07281625
Enrollment
60
Registered
2025-12-15
Start date
2025-10-01
Completion date
2025-12-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Keywords

laminectomy, spinal stenosis, lumbar fusion, VAS pain score

Brief summary

Lumbar spinal stenosis is a condition where the spinal canal becomes narrowed and can cause symptoms such as back pain, numbness, leg pain, and difficulty walking. Surgery is often considered when symptoms do not improve with medical treatment. This study will compare two types of surgery used to treat lumbar spinal stenosis: decompressive laminectomy alone and decompressive laminectomy with transpedicular screw fixation. Patients will be randomly assigned to one of the two surgical options. The purpose of this study is to determine which approach provides better pain relief, improved function, fewer complications, and better spinal stability after surgery.

Detailed description

Lumbar spinal stenosis (LSS) is a common degenerative spinal disorder causing neurogenic claudication, back pain, radiculopathy, and functional limitation. Multilevel stenosis is frequently associated with degenerative disc disease and facet joint hypertrophy. Decompressive laminectomy is a widely performed procedure; however, concerns exist regarding postoperative instability, which may affect long-term outcomes. Instrumented fixation using transpedicular screws may provide stability but also increases operative time, surgical risk, and healthcare cost. This randomized controlled trial will be conducted at the Department of Neurosurgery, Services Hospital Lahore, over a six-month period. A total of 60 participants aged 30-60 years with MRI-confirmed multilevel lumbar spinal stenosis who have failed six weeks of conservative treatment will be enrolled using consecutive sampling and randomized into two equal study groups. Group A will undergo decompressive laminectomy alone, while Group B will undergo decompressive laminectomy with transpedicular screw fixation. b2bf342f-1787-4c2e-828b-e000ffb… Outcome measures will include operative time, postoperative complications, length of hospital stay, pain assessed using the Visual Analog Scale (VAS) at baseline, day 7, and 3 months, and functional status assessed using the Oswestry Disability Index (ODI) at baseline and 3 months. Postoperative radiographs will be used to evaluate spinal stability and bony fusion at 3 months. b2bf342f-1787-4c2e-828b-e000ffb… Data will be analyzed using SPSS version 25. Continuous variables will be presented as mean ± standard deviation and analyzed using an independent sample t-test. Categorical variables will be compared using the chi-square test, with a significance threshold of p ≤ 0.05. The study aims to evaluate whether decompression alone or decompression with transpedicular fixation results in superior clinical and radiological outcomes. b2bf342f-1787-4c2e-828b-e000ffb…

Interventions

Surgical removal of the vertebral lamina to decompress the spinal canal in patients with multilevel lumbar spinal stenosis. No instrumentation or fixation is applied.

PROCEDUREDecompressive Laminectomy With Transpedicular Screw Fixation

Surgical decompression via laminectomy combined with spinal stabilization using transpedicular pedicle screws for multilevel lumbar spinal stenosis to prevent postoperative instability and provide bony fusion.

Sponsors

Punjab Health Care Commission
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age 30-60 years * Diagnosis of lumbar spinal stenosis based on MRI criteria (anteroposterior canal diameter \<10-15 mm or cross-sectional area \<75-145 mm²) * Multilevel disc herniation * Degenerative disc disease with Pfirrmann grade 3-5 on T2-weighted MRI * Failure of at least six weeks of conservative treatment

Exclusion criteria

* Previous history of lumbar spine surgery * Spinal malignancy * Congenital lumbar spinal stenosis, scoliosis, or kyphoscoliosis * Lumbar spondylolisthesis grade 3-5 * Significant comorbidities including diabetes mellitus or ischemic heart disease

Design outcomes

Primary

MeasureTime frameDescription
Change in Oswestry Disability Index (ODI)Baseline and 3 months after surgeryFunctional disability will be assessed using the Oswestry Disability Index (ODI), recorded preoperatively and at 3-month follow-up to measure improvement in functional outcome.

Countries

Pakistan

Contacts

Primary ContactHira Umar, MBBS
quickcareclinicdr03@gmail.com+92 317 4226862
Backup ContactFazal Rehman, MBBS
fazal171@gmail.com03227793559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026